Committee For Medicinal Products For Human Use adopts positive opinion recommending authorization of Omicron BA.4-BA.5 targeting bivalent Covid-19 vaccine in the European Union
Moderna, Inc., has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization for mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID-19
Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Spikevax bivalent Original/Omicron BA.4-5. This vaccine now joins Moderna's other updated booster vaccine, mRNA 1273.214, that targets the BA.1 variant, for use in individuals 12 years and older.
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